The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients.

Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.

6 Minute Walk Distance [ Time Frame: The 6-MWD will be measured at 0 and 3 months. ] [ Designated as safety issue: No ]

Change in 6 Minute Walk Distance from Baseline to 3 Months

Secondary Outcome Measures:

Systemic Markers of Oxidant Stress [ Time Frame: Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months. ] [ Designated as safety issue: No ]

Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.

Any condition other than IPF likely to result in the death of the participant within the next two years.

History of unstable or deteriorating cardiac or neurologic disease.

Pregnancy or lactation. Patients who are: (a) pregnant or (b) breast feeding are excluded from the study.

Current treatment with corticosteroids (either oral or inhaled), Cytoxan, azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or endothelin receptor blockers. Prior treatment is permitted, but at least four weeks of treatment washout prior to inclusion in this study are required.

Investigational therapy for any indication within 28 days prior to enrollment.

Degenerative arthritis, cerebrovascular accident or other limitation to mobility preventing completion of the 6-minute walk test.

Oxygen saturation on room air <80% at rest.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118221